Mechanical Low Back PainPold-LBPNCT01591824
Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
A study testing Resonant oscillation and column exercise group in people with Mechanical Low Back Pain, run by Omphis Foundation at 1 site in Spain.
Trial summary
Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Resonant oscillation and column exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations.
- No previous trauma.
- Age between 25 and 65.
- With similar clinical characteristics to have a homogenous group:
- Low back pain (> 3 months) and that at the time the study began have a minimum of 3/10 on VAS scale, following the criteria established in similar studies
- without component of neurological lower limbs irradiation
Who cannot join
- Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study.
- Existence of irradiation metameric to lower limbs
- Current tumors in the lumbar region
- Ongoing infectious disease in the lumbar area.
- Inflammatory rheumatism in the lumbar region.
- Lumbar surgery complications.
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- Ongoing pregnancy.
- They have been treated with infiltrations in the last month.
- Who are following any other treatment, whether manual or physical agents or alternative or complementary therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold Concept"), another group that applies the standard protocol of treatment for this condition, as used in the hospital where performed the study.
It will compare the levels of efficiency and effectiveness of each treatment and the comparison between them. This will measure the perception of pain intensity and disability.
Read the detailed description
Type of study:
This is an analytical study, the experimental group clinical trial type, controlled, randomized with complete randomization and single blind.
Two groups, the study to which the POLD treatment shall apply, and the control group with conventional treatment will be formed by complete randomization system as they arrive for consultation, with a total of 50 patients or more if they were needed for each group have a minimum of 25 having offset dropouts. The number of 25 patients per group is determined considering accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, are required at least 21 subjects in each group to detect a minimum difference of 15 percentage points between the two groups, therefore two groups of 25 assuming a standard deviation of 15 points and a loss rate of 0% tracking form.
We will study both the effectiveness and efficiency individually and comparatively between groups.
- Study population:
- The sample was selected from patients attending the clinic with back pain and after medical diagnosis are referred to the physiotherapist report of diagnosis, prescribing physical therapy and who meet the criteria for inclusion and not exclusion .
- A total of 25 patients in the experimental group and 25 for the standard treatment group are selected.
- If losses to the sample will be replaced by others to maintain proportions.
- The selection of groups:
RANDOM will be used , he formed the experimental group and control directing patients overall are being incorporated randomly according to the study :
- Group A ( study ) will apply the technique with an identical protocol POLD them all.
- Group B (conventional control) was applied average conventional treatment of different physiotherapy centers of reference.
- Study variables to collect:
- Subjective assessment of pain intensity using VAS, visual analog pain. ,
- Evolution of disability by Oswestry test.
- SF-12 on health.
- Statistical analysis:
Computer analysis using "SPSS" 13.0 ® processed program. The study will be processed as follows:
First, an initial analysis was performed to verify that there were no significant differences between groups in baseline values of the dependent variables by Student's t test for independent samples.
Second : For each dependent variable variance analysis is applied using a general linear model with 2x10 between subjects factor we call variable " Treatment " with two categories 1, 2 (experimental group = 1, conventional group = 2 ) and a temporal within-subjects factor we call "SHOOT" ( 10 sessions) .
Third: We analyze to what treatment session the differences between the two groups appear by Student's t test for independent data after the first session
Fourth, the interactions are studied by comparing the two groups after the first, fifth and 10th session using a Student t test for independent data and comparing the results of each group between 1st and 5th session and between 1st and 10th session with a Student t for paired data.
- Ethical Issues: During the study of national and international guidelines (code of ethics, Declaration of Helsinki) will continue, likewise the legal regulations on data privacy (Law 15 /1999 of 13 December on the Protection of Personal Data)
- Conditions
- Mechanical Low Back Pain
- Being tested
- Resonant oscillation, column exercise group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonant oscillationOther
Also called oscillatory movement
Resonant sustained oscillations are applied in the following areas
- general column.
- lumbar muscles, and paraspinal muscles,
- sacral decompression oscillatory
- Opening by lateral vertebral lumbar rhythmic swing.
- Balancing and pelvic decompression
- Swing-lumbar vertebral rotation.
column exercise groupOther
Also called motor control
- paraspinal muscle stretching exercises
- postural correction
- mobilization exercises thoracic and lumbar
- Motor control exercises
| Study group | Role | What they receive |
|---|---|---|
| POLD TREATMENT | Experimental | Patients who applies the treatment of resonant oscillation according to the Pold Concept Receives: Other: Resonant oscillation |
| CONVENCIONAL: column exercise group | Active comparator | Patients who applied the conventional treatment of hospital Receives: Other: column exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain measurement
Visual analog scale of pain measurement, with values between zero and ten where zero is total absence of pain and 10 the maximum pain imaginable by the patient, distributed in a horizontal line, without intermediate numerical or graphic references.
Measured: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Secondary outcomes (2)
SF-12 Health Survey
The Health Questionnaire SF-12 is the adaptation made for Spain of the SF-12 Health Survey. The SF-12 is a reduced version of the SF-36 Health Questionnaire.
This instrument provides a profile of the state of health and is one of the most widely used generic scales in the evaluation of clinical outcomes, being applicable both for the general population and for patients with a minimum age of 14 years and both in descriptive studies and in evaluation.
It consists of 12 items from the 8 dimensions of SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1), Pain body (1), General Health (1). Response options form Likert-type scales that evaluate intensity or frequency.
The number of response options ranges from three to six, depending on the item
Measured: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Oswestry Disability Index
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.
The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omphis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JUAN V. LOPEZ DIAZ, Omphis Foundation
- Investigators
- José M. Muniesa, physiatrist, Study director, Esperanza Hospital (Barcelona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591824
- Sponsor's protocol ID
- Pold-LBP
- Acronym
- Pold-LBP
- Status last verified
- Apr 2019
- First submitted
- 1 May 2012
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT01591824
- Acronym / sponsor ID
- Pold-LBP / Pold-LBP
- Conditions
- Mechanical Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Omphis FoundationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold Concept"), another group that applies the standard protocol of treatment for this condition, as used in the hospital where performed the study.
It will compare the levels of efficiency and effectiveness of each treatment and the comparison between them. This will measure the perception of pain intensity and disability.
Detailed description
Type of study:
This is an analytical study, the experimental group clinical trial type, controlled, randomized with complete randomization and single blind.
Two groups, the study to which the POLD treatment shall apply, and the control group with conventional treatment will be formed by complete randomization system as they arrive for consultation, with a total of 50 patients or more if they were needed for each group have a minimum of 25 having offset dropouts. The number of 25 patients per group is determined considering accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, are required at least 21 subjects in each group to detect a minimum difference of 15 percentage points between the two groups, therefore two groups of 25 assuming a standard deviation of 15 points and a loss rate of 0% tracking form.
We will study both the effectiveness and efficiency individually and comparatively between groups.
- Study population:
- The sample was selected from patients attending the clinic with back pain and after medical diagnosis are referred to the physiotherapist report of diagnosis, prescribing physical therapy and who meet the criteria for inclusion and not exclusion .
- A total of 25 patients in the experimental group and 25 for the standard treatment group are selected.
- If losses to the sample will be replaced by others to maintain proportions.
- The selection of groups:
RANDOM will be used , he formed the experimental group and control directing patients overall are being incorporated randomly according to the study :
- Group A ( study ) will apply the technique with an identical protocol POLD them all.
- Group B (conventional control) was applied average conventional treatment of different physiotherapy centers of reference.
- Study variables to collect:
- Subjective assessment of pain intensity using VAS, visual analog pain. ,
- Evolution of disability by Oswestry test.
- SF-12 on health.
- Statistical analysis:
Computer analysis using "SPSS" 13.0 ® processed program. The study will be processed as follows:
First, an initial analysis was performed to verify that there were no significant differences between groups in baseline values of the dependent variables by Student's t test for independent samples.
Second : For each dependent variable variance analysis is applied using a general linear model with 2x10 between subjects factor we call variable " Treatment " with two categories 1, 2 (experimental group = 1, conventional group = 2 ) and a temporal within-subjects factor we call "SHOOT" ( 10 sessions) .
Third: We analyze to what treatment session the differences between the two groups appear by Student's t test for independent data after the first session
Fourth, the interactions are studied by comparing the two groups after the first, fifth and 10th session using a Student t test for independent data and comparing the results of each group between 1st and 5th session and between 1st and 10th session with a Student t for paired data.
- Ethical Issues: During the study of national and international guidelines (code of ethics, Declaration of Helsinki) will continue, likewise the legal regulations on data privacy (Law 15 /1999 of 13 December on the Protection of Personal Data)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLD TREATMENT | Experimental | Other: Resonant oscillationPatients who applies the treatment of resonant oscillation according to the Pold Concept |
| CONVENCIONAL: column exercise group | Active comparator | Other: column exercise groupPatients who applied the conventional treatment of hospital |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations.
- No previous trauma.
- Age between 25 and 65.
- With similar clinical characteristics to have a homogenous group:
Key exclusion criteria (9 listed)
- Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study.
- Existence of irradiation metameric to lower limbs
- Current tumors in the lumbar region
- Ongoing infectious disease in the lumbar area.
- Inflammatory rheumatism in the lumbar region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resonant oscillationAlso: oscillatory movementResonant sustained oscillations are applied in the following areas * general column. * lumbar muscles, and paraspinal muscles, * sacral decompression oscillatory * Opening by lateral vertebral lumbar rhythmic swing. * Balancing and pelvic decompression * Swing-lumbar vertebral rotation. | Other | POLD TREATMENT |
| column exercise groupAlso: motor control* paraspinal muscle stretching exercises * postural correction * mobilization exercises thoracic and lumbar * Motor control exercises | Other | CONVENCIONAL: column exercise group |
Primary outcome
VAS pain measurement
Time frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Visual analog scale of pain measurement, with values between zero and ten where zero is total absence of pain and 10 the maximum pain imaginable by the patient, distributed in a horizontal line, without intermediate numerical or graphic references.
2 secondary outcomes
SF-12 Health Survey
Time frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Oswestry Disability Index
Time frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Click here for more information about Omphis Foundation activities, Clinic, teaching and researchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M. Muniesa, physiatrist study director
Esperanza Hospital (Barcelona)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonant oscillation and column exercise group in people with Mechanical Low Back Pain, run by Omphis Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain measurement (time frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.